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Enrollment on target in Parkinson’s
trial
A study co-led by MUSC of a drug that could slow the progression of
Parkinson’s disease is on target with patient enrollment, according to
drug-maker Avicena Group Inc., which develops central nervous system
therapeutics for neurodegenerative diseases.
The Phase III trial for the drug candidate, PD-02, is sponsored by the
National Institutes of Health’s National Institute of Neurological
Disorders and Stroke, and has enrolled 288 patients so far.
Ultimately, this phase of the trial will enroll more than 1,720
patients at more than 50 sites in the United States and Canada, making
it one of the largest Parkinson’s disease trials ever conducted. The
lead investigators are MUSC’s Barbara C. Tilley, Ph.D., Distinguished
University Professor, Department of Biostatistics, Bioinformatics and
Epidemiology chair, and Karl Kieburtz, M.D., of the University of
Rochester in New York.
“The rapid pace of enrollment underscores the unmet treatment need
among 1 million Parkinson’s disease sufferers in the U.S.,” said
Belinda Tsao-Nivaggioli, Ph.D., Avicena’s chief exe-cutive officer.
PD-02 is a proprietary thera-peutic for the treat-ment of Parkinson’s
disease. Data from Phase II efficacy trials conducted at the University
of Rochester showed PD-02 to be safe and well tolerated. Furthermore,
findings demonstrated PD-02’s potential to slow the rate of disease
progression as measured by the Unified Parkinson’s Disease Rating
Scale. Results were published in the Journal of Neurology. In
preclinical studies of Parkinson’s disease, PD-02 has demonstrated
significant neuroprotective properties including protection of the
dopaminergic cells that are affected in Parkinson’s disease.
Parkinson’s disease is an incurable, progressive and neurodegenerative
brain disorder that occurs when the neurons that are responsible for
producing the chemical dopamine die. Primary symptoms of the disease
include involuntary shaking of the arms or legs (tremors), difficulty
with balance, slowness of movement, and stiffness.
The Parkinson’s Disease Foundation reports that roughly 1.5 million
Americans are affected by Parkinson’s disease, making it the second
most common neurodegenerative disease after Alzheimer’s disease. About
60,000 new cases are diagnosed each year in the United States.
Friday, Aug. 3, 2007
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